Healthy Japanese and Caucasian Subjects Clinical Trial
Official title:
A Single-Centre, Investigator/Subject Blind, Placebo-Controlled, Single and Multiple Oral Dose Investigation of Safety, Tolerability, and Pharmacokinetics of UCB0942 in Healthy Japanese and Caucasian Subjects
| Verified date | August 2017 |
| Source | UCB Pharma |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of UCB0942 in Japanese and Caucasian subjects.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | August 14, 2017 |
| Est. primary completion date | August 14, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 55 Years |
| Eligibility |
Inclusion Criteria: - Subject is male or female and between 20 and 55 years of age (inclusive) - Subject is in good physical and mental health - Female subjects will use an efficient form of contraception for the duration of the study (unless menopausal) - Male subject agrees that, during the study period, when having sexual intercourse with a woman of childbearing potential, he will use an efficient barrier contraceptive AND that the respective partner will use an additional efficient contraceptive method - For Japanese subjects: Subject is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has all 4 Japanese grandparents born in Japan) - For Caucasians: Subject is of Caucasian descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has 4 Caucasian grandparents). Exclusion Criteria: At screening: - Previous study participation with another investigational medicinal product (IMP) within 3 months - History of alcohol/drug abuse - History of psychiatric condition and suicide attempt - Any medical condition unfit for study (including history of cancer) - History of hypersensitivity for IMP components - Taking concomitant medications - Positive for human immunodeficiency virus (HIV)/ hepatitis B virus (HBV)/ hepatitis C virus (HCV) - Abnormal liver function tests (LFTs), abnormal safety bloods/ vitals/ physical examination and electrocardiogram (ECG) findings - Positive for pregnancy test - Other protocol-defined exclusion criteria may apply |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Up0039 001 | London |
| Lead Sponsor | Collaborator |
|---|---|
| UCB Biopharma S.P.R.L. |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cmax: maximum observed plasma concentration of UCB0942 and metabolites | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | ||
| Primary | AUC(0-t): area under the plasma concentration-time curve from time zero to the time of last detectable concentration for UCB0942 and metabolites | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | ||
| Secondary | tmax: time of maximum concentration of UCB0942 and metabolites during the Single-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | ||
| Secondary | tmax: time of maximum concentration of UCB0942 and metabolites during the Multiple-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | ||
| Secondary | AUC: area under the plasma concentration-time curve from time zero to infinity for UCB0942 and metabolites during the Single-dose period | AUC is calculated as AUC(0-t)+Clast/kel, where Clast is the last observed quantifiable plasma concentration and kel is the apparent terminal elimination rate constant | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | |
| Secondary | t1/2: apparent terminal elimination half-life of UCB0942 and metabolites during the Single-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | ||
| Secondary | t1/2: apparent terminal elimination half-life of UCB0942 and metabolites during the Multiple-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | ||
| Secondary | RCmax: Accumulation ratio of Cmax for UCB0942 and metabolites during the Multiple-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | ||
| Secondary | AUCtau: area under the curve over a dosing interval (12hrs) for UCB0942 and metabolites during the Single-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | ||
| Secondary | AUCtau: area under the curve over a dosing interval (12hrs) for UCB0942 and metabolites during the Multiple-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | ||
| Secondary | RAUC: Accumulation ratio of AUCtau for UCB0942 and metabolites during the Multiple-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | ||
| Secondary | Adverse events (AEs) reported spontaneously by the subject or observed by the investigator | From Screening until safety follow up visit (up to Week 18) | ||
| Secondary | Change from baseline in laboratory variables, vital sign variables, 12-lead ECG variables and physical examination | From Baseline until safety follow up visit (up to Week 18) |